Dextrose Monohydrate, Sodium Chloride
FDA Drug Information • Also known as: Dextrose And Sodium Chloride
- Brand Names
- Dextrose And Sodium Chloride
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in single-dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 . Table 1. * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Size (mL) Composition (g/L) *Osmolarity (mOsmol/L) (calc.) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) **Dextrose Hydrous, USP Sodium Chloride, USP (NaCl) Sodium Chloride 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP 1,000 25 4.5 280 4.5 (3.2 to 6.5) 77 77 85 Dextrose is derived from corn. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. structural formula
What Is Dextrose Monohydrate, Sodium Chloride Used For?
1 INDICATIONS AND USAGE 2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. 2.5% Dextrose and 0.45% Sodium Chloride Injection is indicated as a source of water, electrolytes and calories. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Only for intravenous infusion. ( 2.1 ) See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. ( 2.1 , 2.2 , 2.3 ) 2.1 Important Administration Instructions 2.5% Dextrose and 0.45% Sodium Chloride Injection is only for intravenous infusion. The osmolarity of 2.5% Dextrose and 0.45% Sodium Chloride Injection, is 280 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain. Do not administer 2.5% Dextrose and 0.45% Sodium Chloride Injection simultaneously with blood products through the same administration set because of the possibility of pseudoagglutination or hemolysis. To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. Prior to infusion, visually inspect the solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged. Use of a final filter is recommended during administration of parenteral solutions, where possible. 2.2 Recommended Dosage The choice of the specific, sodium chloride, and dextrose concentrations, rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient. The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient's tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.4 )] . 2.3 Instructions for Use Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. Flexible Plastic Container ( free flex ® bag) To Open Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates. Preparation for Administration Immediately before inserting the infusion set, break off BLUE Infusion Port...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following adverse reactions associated with the use of 2.5% Dextrose and 0.45% Sodium Chloride Injection were identified in postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions: anaphylaxis, rash and pruritus [see Warnings and Precautions ( 5.1 )] . Metabolism and Nutrition Disorders: hyperglycemia [see Warnings and Precautions ( 5.2 )] , hyponatremia and hyponatremic encephalopathy, for solutions containing less than 0.9% sodium chloride [see Warnings and Precautions ( 5.3 )] . Hypernatremia and hyperchloremia acidosis [see Warnings and Precautions ( 5.5 )] have been observed in solutions containing 0.9% sodium chloride. Infusion and/or Injection Site Reactions: phlebitis, injection site vesicles, infusion site pain, chills and pyrexia. Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
7 DRUG INTERACTIONS Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance: Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. ( 7.1 ) Lithium: Decreased lithium concentrations with concomitant use; monitor serum lithium concentrations. ( 7.2 ) 7.1 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance 2.5% Dextrose and 0.45% Sodium Chloride Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 , 5.5 , 5.6 )] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using 2.5% Dextrose and 0.45% Sodium Chloride Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance. 7.2 Lithium Renal sodium and lithium clearance may be increased during administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection resulting in decreased serum lithium concentrations. Monitor serum lithium concentrations during concomitant use.
Contraindications
4 CONTRAINDICATIONS 2.5% Dextrose and 0.45% Sodium Chloride Injection is contraindicated in patients with: known hypersensitivity to dextrose and/or sodium chloride [see Warnings and Precautions 5.1 )] clinically significant hyperglycemia [see Warnings and Precautions ( 5.2 )] Known hypersensitivity to dextrose, or sodium chloride ( 4 , 5.1 ) Clinically significant hyperglycemia ( 4 , 5.2 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Appropriate administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with 2.5% Dextrose and 0.45% Sodium Chloride Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Overdosage
10 OVERDOSAGE Excessive administration of 2.5% Dextrose and 0.45% Sodium Chloride Injection can cause: Electrolyte and Fluid Disorders Hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance, and corresponding complications, which can be fatal [see Warnings and Precautions ( 5.2 )] . Hyponatremia, manifestations may include seizures, coma, cerebral edema and death) [see Warnings and Precautions ( 5.3 )] . Hypernatremia, especially in patients with severe renal impairment [see Warnings and Precautions ( 5.5 )] . Fluid overload (which can lead to central and/or peripheral edema) [see Warnings and Precautions ( 5.6 )] . When assessing an overdose, any additives in the solution must also be considered. Clinically significant overdose of 2.5% Dextrose and 0.45% Sodium Chloride Injection may, therefore, constitute a medical emergency. The effects of an overdose may require immediate medical attention and treatment. Interventions include discontinuation of the infusion, dose reduction, monitoring of fluid balance, electrolyte concentrations and acid-base balance and institution of appropriate corrective measures such as administration of exogenous insulin.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 2.5% Dextrose and 0.45% Sodium Chloride is a clear solution in 1000 mL single-dose, flexible containers available as follows: Product Name Size (mL) Number per Carton NDC Product Code 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP 1,000 10 63323-874-10 874010 Storage: Avoid excessive heat. Store at 20° to 25°C (68° to 77°F) [ see USP Controlled Room Temperature]; brief exposure up to 40°C/104°F does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.